hydroxyzine hydrochloride

Generic: hydroxyzine hydrochloride

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydroxyzine hydrochloride
Generic Name hydroxyzine hydrochloride
Labeler ani pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

hydroxyzine dihydrochloride 10 mg/5mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-912
Product ID 70954-912_43889411-a303-41a1-b03b-1ee46f452c54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219648
Listing Expiration 2026-12-31
Marketing Start 2026-01-15

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954912
Hyphenated Format 70954-912

Supplemental Identifiers

RxCUI
995241
UPC
0370954912101
UNII
76755771U3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydroxyzine hydrochloride (source: ndc)
Generic Name hydroxyzine hydrochloride (source: ndc)
Application Number ANDA219648 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (70954-912-10)
source: ndc

Packages (1)

70954-912-10 473 mL in 1 BOTTLE (70954-912-10)

Ingredients (1)

hydroxyzine dihydrochloride (10 mg/5mL)

Linked Drug Pages (1)

Hydroxyzine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43889411-a303-41a1-b03b-1ee46f452c54", "openfda": {"upc": ["0370954912101"], "unii": ["76755771U3"], "rxcui": ["995241"], "spl_set_id": ["43889411-a303-41a1-b03b-1ee46f452c54"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (70954-912-10)", "package_ndc": "70954-912-10", "marketing_start_date": "20260115"}], "brand_name": "Hydroxyzine Hydrochloride", "product_id": "70954-912_43889411-a303-41a1-b03b-1ee46f452c54", "dosage_form": "SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]"], "product_ndc": "70954-912", "generic_name": "Hydroxyzine Hydrochloride", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydroxyzine Hydrochloride", "active_ingredients": [{"name": "HYDROXYZINE DIHYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "ANDA219648", "marketing_category": "ANDA", "marketing_start_date": "20260115", "listing_expiration_date": "20261231"}